SOPs for Analytical Method Development V 2.0

This SOP describes the procedure for the development of an HPLC method for the estimation of residual solvents in active pharmaceutical ingredients (APIs) and drug products. The method aims to identify and quantify Class 2 solvents as per ICH Q3C guidelines.
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This SOP describes the procedure for developing and executing a High-Performance Liquid Chromatography (HPLC) method for estimation of residual solvents in active pharmaceutical ingredients (APIs) and finished pharmaceutical products, particularly where gas chromatography (GC) is unsuitable due to volatility or matrix interferences.
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The purpose of this SOP is to define the standard procedure for conducting carryover studies during HPLC method development. Carryover evaluation ensures that no significant contamination is transferred from one injection to the next, thereby maintaining the integrity and reproducibility of results.
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This SOP provides a structured approach for designing and evaluating system suitability parameters during HPLC method development. Establishing robust system suitability ensures chromatographic system integrity and reliable analytical results.
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This SOP describes the strategy and step-by-step procedures for preparing samples for HPLC analysis in the context of method development. Proper sample preparation ensures accuracy, precision, reproducibility, and analyte stability during quantitative and qualitative analysis.
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This SOP describes the procedure for developing a gas chromatographic (GC) method for the identification and quantification of residual solvents in pharmaceutical substances and finished drug products. The method ensures compliance with ICH Q3C guidelines and supports regulatory submissions.
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This SOP defines the standard procedure for the optimization of GC Headspace methods for estimation of residual solvents in pharmaceutical raw materials and finished products. The aim is to ensure accurate, precise, and reproducible analysis as per ICH Q3C and regulatory requirements.
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This SOP outlines the methodology for developing a gas chromatographic (GC) assay for volatile active pharmaceutical ingredients (APIs). It ensures accurate quantification, sensitivity, and regulatory compliance using validated GC parameters and techniques.
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This SOP outlines the standard procedures for implementing derivatization techniques in gas chromatography (GC) for the purpose of enhancing the analytical performance of non-volatile, polar, or thermally labile compounds during method development.
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This SOP describes the step-by-step setup, calibration, operation, and maintenance of Flame Ionization Detector (FID) used in gas chromatography (GC) for analytical method development in pharmaceutical laboratories. The procedure ensures accurate, sensitive, and reliable quantification of organic analytes.
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